This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active Crohn's disease. Eligible subjects include males and females aged 18-75 years with moderately to severely active CD for at least 3 months. Each subject will receive the assigned treatment over 12 weeks, followed by a 4-week safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
Change from baseline to Week 12 in Crohn's Disease Activity Index score
Crohn's Disease Activity Scale will be assessed by collecting information on 8 different Crohn's Disease-related variables : extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stood, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variable are based on dairy of patient for 7 days Scale range is 0 to 600 with 0 being the best oputcome and a score of 600, the worst outcome.
Time frame: 12 weeks
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Clinical Site
Innsbruck, Austria
Clinical Site
Klagenfurt, Austria
Clinical Site
Sankt Pölten, Austria
Clinical Site
Sankt Veit an der Glan, Austria
Clinical Site
Vienna, Austria
Clinical Site
Berlin, Germany
Clinical Site
Hamburg, Germany
Clinical Site
Kiel, Germany
Clinical Site
Landshut, Germany
Clinical Site
Ulm, Germany
...and 41 more locations